Overview

Coastal Carolina Research Center is a dedicated research facility located in Mt. Pleasant which is within the greater Charleston, South Carolina metro area.. We were founded in 1997 and are the proud recipients of the Charleston, South Carolina Small Business of the Year for 2000. We provide
access to the clinical research process to thousands of Charleston
Lowcountry citizens who are interested in volunteering and
participating in clinical trials and research studies that focus on
primarily “outpatient” studies in multiple therapeutic areas and
diseases.

CCRC has established a reputation in the industry for defensible
data and high, rapid enrollment. Our site conducts studies in
multiple therapeutic areas which are amenable to our existing
research population and allows us to gain further interest from
volunteers in the community through strategic recruitment and
advertising. . For these trials we utilize a core group of
physicians of various specialists who serve as Pis and
sub-investigators. Dr. Cynthia B. Strout serves as our medical
director and is a full-time research physician. CCRC's
physicians are very dedicated and believe in extensive patient
interaction in the trials they oversee.

Most Compelling Opportunity

To replace the public’s fear and misconception of Coastal
Carolina Research Center’s work in clinical research, with a full
understanding of, appreciation for, and involvement in the positive
impact trial results have in the lives of participants and the
world at large.

Experience

CCRC conducts trials in Phases II, III, and IIIb/IV.

Our center has conducted studies in the following therapeutic
areas:

Acne

ADHD

Allergic Rhinitis

Alzheimer’s Disease

Anthrax Vaccine

Anxiety

Atrial Fibrillation

Binge Eating

Biodefense Vaccine

Bipolar Disorder

BPH

Cholera Vaccine

Chronic Lower Back Pain

Cold Sores (Herpes Labialis)

Colo-rectal Cancer Detection

Common Cold

Contraception

Depression

COPD

Dementia

Diabetes (Type I)

Diabetes (Type II)

Diabetic Peripheral Neuropathy

Dyslipidemia

Dyspepsia

Epilepsy

Erectile Dysfunction

Erosive Esophagitis

Exacerbation of Chronic Bronchitis

Female Sexual Dysfunction

Flu Vaccine (all ages)

Fibromyalgia

Genetic Biomarkers

Genital Herpes

Genital Warts

GERD

Gout

Healthy Volunteer

Heartburn

Hepatitis

Herpes Zoster (Shingles) Vaccine

H5NI (Avian) Flu Vaccine

H1N1 (Swine) Flue Vaccine

HIV

Hormone Replacement Therapy

Hot Flashes

HPV Vaccine

Human Papillomavirus (HPV)

Hypertension (including Ambulatory BP
Monitoring)

Hypercholesterolemia (Cholesterol)

Hypogonadism

Influenza

Insomnia

Insomnia with PSG's

Irritable Bowel Syndrome

Macular Degeneration

Male erectile dysfunction

Medical Devices

Meningococcal Vaccine

Menstrual Migraines

Metabolic Syndrome

Migraine headaches

Migraines (Adolescent)

Migraine Prevention

Multiple Sclerosis

Neuropathic Pain

Nocturia

Obesity

Obesity in Diabetes

Obesity with dyslipidemia

Onychomycosis

Opioid Induced Constipation (OIC)

Osteoarthritis

Osteoarthritis of the knee

Osteoarthritis of the hip

Osteoporosis

Otitis Media

Overactive Bladder

Over-the-Counter Medications

Pandemic Flu Vaccine

Pediatric Nutraceuticals

Pharyngitis

Plague Vaccine

Pre-Menstrual Syndrome

Pneumonia

Pneumococcal Vaccine

Psoriasis

Restless Leg Syndrome

Rheumatoid Arthritis

Rosacea

Seasonal Allergic Rhinitis

Seasonal Flu Vaccine

Smoking Cessation

Stress Urinary Incontinence

Tension Headaches

Tinea Capitis (Ringworm of scalp)

Tinea Pedis (Athlete’s Foot)

Toenail Fungus

Ulcers

Urinary Tract Infections

Vaginal Atrophy

Weight Loss

We have worked with the following sponsors:

Abbott

Achelios Therapeutics

Abbvie

Aegerion

Afferent

Alder

Agile Therapeutics

Allergen

Alpharma

Altana

Amylin

Amgen

Ampio

Antares

Ardea Biosciences

Arena

Astellas

AstraZeneca

Aventis

Barr

Baxter Healthcare

Bayer

Beechtree Labs

Berlex

Bertek

Biodelivery Sciences

Biogen

Bionovo

Biovail

Bioventus

Boehringer Ingelheim

Bristol-Myers Squibb

Calosyn

Centocor

Cipher

Collagenex

Covidien

Daiichi Sankyo

DepoMed

Dong-A

Dow

Dupont Merck

Duramed

Dynport (DVC)

Eli Lilly

Elcelyx Therapeutics

Emergent Biosolutions

Epigenomics

Esperion Therapeutics

Exact Science

Ferring

Flexion Therapeutics

Forbes Medi-Tech

Forest

Furiex

G&W Labs

Galderma

Genentech

Genomic Collaboration

Genzyme

Gilead

GlaxoSmithKline (GSK)

GlaxoSmithKline Biologicals

Glaxo Wellcome

Glenmark Pharmaceuticals

Hoechst-Marion Roussel

Hoffman LaRoche

IDEA AG

Hoffman LaRoche

Impax Laboratories

Insmed

Janssen

Jazz Pharmaceuticals

Johnson & Johnson

Jonssen

King

KOS Pharmaceuticals

Kowa Pharmaceuticals

Labrys Biologics

Lexicon Pharmaceuticals

Lifecycle Pharma

Marine Polymer Technologies

Maruho

Meade Johnson

Medimmune

Medivir

Merck

Merz Pharmaceuticals

Metabasis Therapeutics

Mylan

Minster

Nabi

NanoBio

Nicox

Neuraxon

Neurogen

Novartis

Novartis Vaccines

Novavax

Noven Pharmaceuticals

Novo Nordisk

Olatec

Omthera

ONO

Optinose

Orexigen Therapeutics

Organon

Ortho McNeil

Otsuka

Pain Therapeutics

Palatin Technologies

PaxVax

Perrigo

Pharmacia

Pharmos

Pfizer

Pozen

Proctor and Gamble

ProEthic

Promius

QLT

Quinnova Pharmaceuticals

Regeneron

Repros Therapeutics

Rhone-Poulenc Rorer

Roche

Roche Diagnostics

R.W.T.

Sankyo

Sanofi-Aventis

Sanofi-Pasteur

Sanofi-Synthelabo

Schering-Plough

Schwarz

Searle

Shionogi

Shire

Solvay

Stiefel Laboratories

Sunovion

Surface Logix

Targacept

Takeda

TAP

Taro

Teva

Therapeutics MD

Tioga

TorreyPines Therapeutics

TransTech

Triangle

Trimel Biopharma

Tylenol

UCB

Vanguard

Vaxinnate

Viamet

Viro Pharma

Vivus

Warner Chilcott

Watson

Wyeth

Wyeth Ayerst

Xenoport

XOMA LTD

Yamanouchi

We have also worked with the following CRO's:

AAI

Amarex

Aptiv Solutions

B & B Clinical Innovations

BBK Healthcare

Beardsworth Consulting

Biorasi

Cato

Chiltern

Clinilabs

Clinimetrics

ClinTrials

Concentrics

Covalent

Covance

CPR

Criterium

CTMS

Cu-Tech

DP Clinical

Duke CRI

Encorium

Essential

Global IQ

Health Decisons

Healthcare Products

Hill Top Research

i3 Innovis

i3 Research

ICON

INC Research

Inclin

Ingenix

Integrium

inVentiv

Inveresk

Kendle

Kern McNeill

LBR

MDS

Medifacts

Medpace

MTRA

NCGS

Novella Clinical

Novum

Omnicare

Paragon

Parexel

Pharmaco

PharmaNet

PharmaResearch

Pharm Olam International

PPD

PRA

PRACS

Premier Research

QDS

Quintiles

Radiant Development

RCRI

RPI

RPS

RTI

Scirex

SRA

STAT PROBE

Symbio Research

Synteract

Target Research Associates

Theradex

Theorem

TKL Research

UBC (United Bioscience)

US Micron

Worldwide Clinical Trials

Facility

The Charleston area is a popular destination due to its mild
climate and historic charm. It is the fastest growing metro area in
South Carolina, with a diverse population that has a positive
attitude towards clinical research. Charleston offers beautiful
beaches, championship golf, world-class restaurants, and a wide
variety of conveniently located hotels and bed-and-breakfasts.

Coastal Carolina Research Center's office is located in
"beautiful" Mt. Pleasant and is about 5 minutes away from
the Cooper River Bridge which crosses over into
"historic" Charleston, South Carolina. This office is
readily accessible (5-10 minutes) to two barrier islands, Isle of
Palms & Sullivan's Island, which are amongst the nicer
beaches on the East Coast. This main office is within 15 minutes of
the Charleston International Airport.

Facility descriptions and equipment for the site are
as follows:

Facility

Mt. Pleasant

Facility Name

Coastal Carolina Research Center

Address

1156 Bowman Road, Suite 102
Mt. Pleasant, SC 29464

Phone #

843/856-3784

Fax #

843/856-3788

Office Space

6,800 square feet located on 1st floor

Parking

Very accessible and Free parking is available

Lobby/Waiting

Cozy waiting room with reading material available. Wait time
for volunteers is generally just a couple of minutes. A spill over
waiting room is available if needed.

Exam Rooms

7

Laboratory

Large CLIA waived lab is in a perfect location for the flow of
patients and staff.

Study Coordinator space

Two large "limited access" spaces are occupied by our
team of nurses, research coordinators, research assistants and
dieticians.

Monitor Rooms

One large room with access to telephone and high-speed internet
services is able to hold 3 to 4 monitors per day. An additional
private office is available if needed to accommodate > 4
monitors.

Staff

Dr. Cynthia Strout is Coastal Carolina Research Center’s Medical Director. Dr. Strout is a certified research professional through ACRP/APPI and has 16 years of research experience. She leads our investigator staff which has a combined 50 years of research experience.

Nancy Dinsmore, RN, President and co-founder has 17 years of research experience.

Nathan Morton, Director has worked within the industry for over 10 years.

Coastal Carolina Research Center’s remaining staff consists of:

9 Study Coordinators (including 3 RNs)

2 Assistant Coordinators

3 Recruitment Specialists

1 Retention Specialist

1 Regulatory Coordinator

2 Data Entry Specialists

2 Laboratory Personnel

1 Dietician

1 Diabetic Educator

2 Administrator Personnel

Patients

The Charleston area is one of the most desirable places to live
in the United States. The population is 63% White, 35% African
American, & 2% Other. Of Charleston's total Metro
Population of 600,000, there is a core of informed, experienced
study patients. Charleston is the "Medical Hub" of the
lower part of South Carolina due to the Medical University of South
Carolina. Our patient population includes a pediatric, adolescent,
adult and a burgeoning elderly population. In July 2006, AARP
published that Charleston was amongst the five (5) best cities for
retirees to live in throughout the United States.

Volunteer Database

Coastal Carolina Research Center (CCRC) currently uses Clinasyst
as our Clinical Trials Management System. Within this confidential
database we maintain the names of over 22,000 Lowcountry citizens who
have either participated in a clinical trial or have submitted
interest in volunteering for clinical trials with CCRC.

This database will allow us to query within minutes by age,
gender, ethnic group and medical diagnosis or history to allow for
quick feasibility surveys. Our database closely resembles the
general demographic information of the Charleston metro area and we
intend to continue to seek clinical study opportunities that would
benefit our entire population.